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Overseas Co-Promotion of Actemra(R), a Treatment for Rheumatoid Arthritis

Tokyo, May 7, 2007 (JCN Newswire) - Chugai Pharmaceutical Co., Ltd. announced today that under the terms of the license agreement signed with F. Hoffmann-La Roche on the humanized anti-human IL-6 receptor monoclonal antibody Actemra, it has decided not to exercise the opt-in right for co-promotion in the United States, Italy and Spain, and will co-promote the product with Roche in France, Germany and the United Kingdom.

In July 2003, Chugai and Roche signed a co-development and co-promotion license agreement granting Roche exclusive rights for Actemra-related patents and trademark usage for the global market excluding Japan, South Korea and Taiwan. Under the agreement, Chugai holds the right for co-promotion in France, Germany and the United Kingdom, and the opt-in right for co-promotion in the United States, Italy and Spain

In France, Germany and the United Kingdom, where Chugai has its own marketing base, the two companies have started joint efforts to build the necessary organization and to plan marketing and promotion strategies. In the United States, Italy and Spain, however, Chugai decided not to exercise the opt-in right in those territories, in pursuit of maximizing the business value of Actemra as early as possible, and in consideration of Chugai's mid-term strategy on overseas activities. Profits will be shared in France, Germany and the United Kingdom in proportion to each company's co-promotion effort.

Chugai and Roche have been advancing the co-development of Actemra globally, and currently phase III clinical trial programs in rheumatoid arthritis are going on in 41 countries worldwide. Four out of five phase III clinical trials are scheduled to be reported by the end of the year, and Roche is planning to file for approval in Europe and in the United States in the latter part of 2007.

Chugai and Roche aims to maximize the value of Actemra through collaboration efforts in both development and marketing activities.

About Actemra(R)

Actemra, created by Chugai in collaboration with Osaka University, utilizes genetic recombinant technology to produce monoclonal antibody from mouse anti-IL-6 receptor monoclonal antibody. It works by inhibiting IL-6 biological activity through competitively blocking the binding of IL-6 to its receptor.
In Japan, Actemra is currently being marketed as a treatment for Castleman's Disease since June 2005, and in April 2006 it was filed for additional indications of rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis.


About Chugai

Chugai Pharmaceutical Co., Ltd. (TSE: 4519) is one of Japan's leading research-based pharmaceutical companies with strengths in biotechnology products and in the therapeutic fields of oncology, renal diseases, cardiovascular diseases, bone/joint diseases and transplantation/infection/immunity. As a most important member of the Roche group, we aim to become a top Japanese pharmaceutical company by providing a continuous flow of innovative new medicines domestically and internationally. For more information, please visit www.chugai-pharm.co.jp.


Contact:

Chugai Pharmaceutical Mamoru Togashi General Manager Corporate Communications Department Tel: +81-3-3273-0881
 
May 7, 2007
Source: Chugai

Chugai (TSE: 4519) (U.S: CHGCF)

From the Japan Corporate News Network
http://www.japancorp.net
Topic: Press release summary


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